Kornimate/medical-research-clean huggingface dataset:
pre-habilitation exercise intervention

Conditions: Inflammatory Bowel Diseases; Colon Cancer; Rectal Cancer; Diverticular Disease

Summary: the purpose of this study is to see whether exercise can improve the health and well-being of patients scheduled to undergo surgery for a bowel related condition.

the proposed randomized controlled trial aims to recruit 60 patients that have a primary diagnosis of either colon or rectal cancer, inflammatory bowl disease, or diverticular disease and are scheduled for elective surgery. this two-arm clinical trial of an intervention examining the efficacy of a home-based walking and progressive resistance exercise program for the relief of post-operative fatigue and improvement of functional outcome following surgery.

Eligibility criteria:
inclusion criteria: * have a primary diagnosis of one of the following: colon or rectal cancer, inflammatory bowel disease, or diverticular disease * be scheduled for elective (non- emergent) surgery * have the approval of their treating physician, study physician, or physician's designee to participate in maximal physiological fitness testing and a low to moderate home-based walking and progressive resistance exercise program. * be able to read english (since the assessment materials will be in a printed format). * be 18 years of age or older * give informed consent. exclusion criteria: * have physical limitations (e.g. cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in maximal physiological fitness testing, or a low to moderate home-based walking and progressive resistance program, as assessed by the par-q+ and clinician (or physician's designee) * must not be in active or maintenance stage of exercise
role of inflammasomes in covid-19 disease

Conditions: COVID-19 by SARS-CoV-2 Infection

Summary: as of march 25, 2020, 414,179 cases and 18,440 deaths secondary to coronavirus 2019 disease (covid-19) have been reported worldwide. the unfavorable course of the patients is characterized on the immunological level by an intense pro-inflammatory response which can go as far as a cytokinic storm. this pandemic affects a naive world population from an immunological point of view with respect to sars-cov-2 responsible for covid-19. the evolution is favorable without hospitalization in almost 85% of cases. among patients hospitalized for pneumonia, some will not require ventilatory support while others will need intensive care. to date, two main types of unfavorable evolution have been described. the first is a bi-phasic evolution beginning with a paucisymptomatic form which is worsened secondarily with respiratory distress associated with a decrease in the viral load in the airways. the second is associated with persistent high viral loads in the airways and detection of the virus in the blood. these different clinical profiles could depend on the quantitative and qualitative response of the innate immune system. at the early stage of a viral infection the innate immunity is capable of detecting certain conserved microbial patterns (pamp, pathogen-associated molecular pattern) recognized by receptors dedicated to these patterns (prr, pattern recognition receptor). this process allows to initiate the pro-inflammatory response via different signaling pathways. activating multiprotein complexes called inflammasomes, which cause pro-il-1β and pro-il-18 to be transformed into active pro-inflammatory cytokines are one of these pathways. the central role of inflammasomes in the secretion of these pro-inflammatory cytokines deserves an in-depth study of their activation during covid-19, whereas the inadequate inflammatory response appears to be the determining factor in the unfavorable development of patients. the objective of this project is to analyze the level of activation of the inflammasomes and then to search for inactivating or activating mutations among the genes which code for the proteins constituting the inflammasomes in covid-19 patients. the identification of mutations in patients with a serious clinical presentation or even death would be followed by fundamental work by analyzing in a cellular model the impact of these mutations on the secretion of il-1β.


Eligibility criteria:
inclusion criteria: * age above 18 years old. sars-cov-2 infection confirmed by rt pcr or by serology hospitalised patients with less than 14 days of covid-19 symptoms. date of first symptom being defined as to the date of one of the following symptoms : cough, dyspnea, fever above 38 °c, anosmia, dysgeusia or ageusia, chilblain lupus erythematous women of fertile age using at least one contraceptive method health insurance written informed consent exclusion criteria * pregnant or breastfeeding female * human immunodeficiency virus infection with cd4 under 200 cell/mm3 * aplasia * at-risk patients (minor, patient under judicial protection or tutorship)
fractional laser in combination with uvb therapy in vitiligo patients

Conditions: Vitiligo

Summary: rationale: vitiligo is a common skin disorder that can impair a patient's quality of life. many depigmented lesions in vitiligo patients remain therapy resistant for medical treatment. therefore new therapeutic options in these patients are necessary. currently, dermabrasion by conventional or fractional laser therapy in combination with nb-uvb therapy and steroids appears to be effective in therapy resistant areas. however, little literature on this combination is available. objectives: to assess the efficacy and patient safety of (1)fractional co2-laser treatment in combination with nb- uvb,(2) fractional co2-laser treatment in combination with nb- uvb and topical corticosteroids versus nb-uvb treatment alone(3) study design: prospective observer blinded randomised intra-patient controlled study. study population: 23 patients ≥ 18 years with non segmental vitiligo who receive nb-uvb treatment at the netherlands institute for pigment disorders (snip) at the academic medical centre university of amsterdam. we will include patients with 3 depigmented lesions that are resistant to nb- uvb treatment after 3 to 6 months. methods: three nb-uvb resistant depigmented regions on the trunk or extremities will be randomly allocated to;(1) nb-uvb treatment in combination with fractional co2 laser abrasion, or (2) nb-uvb treatment in combination with fractional co2 laser abrasion and topical steroids, or (3) nb-uvb treatment alone. nb-uvb treatment and topical steroids will be given according to the standard treatment protocol of the snip and continued for at least 6 months. two and 6 months after the laser treatment, the percentage of repigmentation of the lesions will be assessed.


Eligibility criteria:
inclusion criteria * patients with non segmental (generalised) vitiligo visiting the netherlands institute for pigment disorders * receiving nb- uvb treatment for 3 to 6 months * age \>18 years * at least 3 therapy resistant vitiligo lesions on the extremities or trunk larger than 5x5 cm or one vitiligo lesion on the extremities or trunk of at least 5x15 cm. * patient is willing and able to give written informed consent exclusion criteria * skin type i * recurrent hsv skin infections * hypertrophic scars * keloid * cardial insufficiency * patients who are pregnant or breast-feeding * patients not competent to understand what the procedures involved * patients with a personal history of melanoma or non-melanoma skin cancer * patients with atypical nevi.

Keywords: ultraviolet therapy non segmental vitiligo topical corticosteroid laser fractional co2 carbon dioxide uvb
ketamine with multilevel paravertebral block for post video-assisted thoracic surgery pain

Conditions: Pain, Acute; Pain, Chronic; Pain, Neuropathic

Summary: postoperative pain after thoracic surgery is associated with adverse outcomes. the current strategy to prevent postoperative pain is the use of regional anesthesia and analgesic agents. in video-assisted thoracic surgery (vats), thoracic paravertebral block has become the standard analgesic regimen which results in decreased postoperative pain and opioid consumption. the investigator would like to study the analgesic efficacy of low dose intravenous ketamine infusion during surgery in combination with thoracic paravertebral block on postoperative pain after vats in a randomized study.

inadequate pain control after thoracic surgery is associated with adverse events such as postoperative pulmonary complications (ppc), and chronic post surgical pain. although the less invasive video-assisted thoracic surgery (vats) has been used extensively as it produces optimal surgical outcomes and possible less postoperative pain, there are reports of inadequate pain control. thoracic paravertebral block (tpvb) has been introduced as an effective method in postoperative pain management after vats. it is associated with improved pain control and the reduction of opioid analgesic consumption in several studies. the use of intravenous low dose ketamine infusion during and after surgery has been shown to produce superior postoperative pain control in upper abdominal surgery and thoracotomy. the aim of the present study is to study the efficacy of intravenous low dose ketamine infusion during surgery on acute and chronic pain after vats.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologist physical status 1-3 * scheduled for elective video-assisted thoracic surgery * able to operate a patient-controlled analgesia device (pca) exclusion criteria: * history of morphine allergy * history of bupivacaine allergy * contraindication for ketamine infusion * contraindication for thoracic paravertebral block * anticipated postoperative positive pressure ventilation * body mass index more than 35 * any known psychiatric disorder

Keywords: anesthesia thoracic surgery thoracic paravertebral block ketamine
to evaluate ezetimibe/simvastatin and niacin (extended release tablet) in patients with type iia or type iib hyperlipidemia (0653a-091)(completed)

Conditions: Hypercholesterolemia

Summary: to evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high cholesterol.


Eligibility criteria:
inclusion criteria: * patient with ldl-c of 130 through 190 mg/dl and triglycerides less than or equal to 500 mg/dl * patient willing to be on a low-cholesterol diet exclusion criteria: * pregnant or lactating women or intending to become pregnant * patient with sensitivity or intolerance to ezetimibe, simvastatin, or ezetimibe/simvastatin combination tablet * patient with sensitivity or intolerance ro niacin, any component or niacin extended release or aspirin * patient for whom discontinuation of existing lipid-lowering therapy treatment poses an unacceptable risk
clinical evaluation of frequency allocation for bimodal ci users

Conditions: Hearing Impairment

Summary: this study will examine experienced, bimodal cochlear implant (ci) patients who receive an alternative frequency allocation table (fat) to determine how it improves sound quality, device satisfaction, and speech perception abilities with respect to the standard default fat. the goal of this study is to investigate how improving place-pitch mismatch in bimodal ci users affects 1) sound quality, 2) satisfaction, and 3) speech perception.


Eligibility criteria:
inclusion criteria: 1. age 18 or older 2. regular usage of a cochlear implant device with at least 18 active electrodes, and compliance with programming/appointments 3. received a cochlear implant at least 6 months ago and use a hearing aid in the contralateral ear 4. pure tone average (.5, 1, and 2khz) between 30 and 70 db (decibel) hearing level in the contralateral (hearing aid) ear 5. standard fat use for all programs prior to study participation 6. no known anatomical abnormalities in either ear 7. english speaking 8. no known cognitive impairments 9. at least 25% of subjects should use the cochlear ea32 electrode exclusion criteria: 1. under age 18 2. non-english speaking. participants that are non-english speaking are excluded from this study due to the use of speech testing materials that are validated in the english language. additionally, study team members are not equipped to appropriately score speech testing materials validated in other languages. 3. cognitively impaired 4. non-consistent device usage 5. greater than 70 db hearing level pure tone average in the contralateral ear 6. normal hearing or mild hearing loss in the contralateral ear 7. non-standard fat programs 8. use of any frequency transposition programming in hearing aid.
diurnal variation in hypertensive stroke patients

Conditions: Hypertension; Stroke

Summary: this study was conducted to evaluate and compare the effectiveness of amodipin® (amlodipine camsylate) with that of cozaar® (losartan potassium) in hypertensive patients with an acute ischemic stroke by measuring their 24-hour ambulatory bp (abp).


Eligibility criteria:
inclusion criteria: 1. aged 35 to 85 years 2. hypertensive patients who had an ischemic stroke exclusion criteria: 1. patients aged below 35 years or above 86 years; 2. patients who had a hemorrhagic stroke; 3. patients whose systolic bp (sbp) was over 220 mmhg or whose diastolic bp (dbp) was above 120 mmhg during an acute phase, or whose sbp was over 180 mmhg or whose dbp was over 110 mmhg one week after their hospital visit; 4. patients with secondary hypertension related to renovascular, endocrinologic, or pregnant conditions 5. patients who went to bed in the middle of the day or very late at night; (6) patients who were using intravenous antico-agulants or thrombolytics; (7) patients with a severe stroke (nih stroke scale \> 20); (8) patients who could not give their consent to investigators; (9) patients with severely impaired liver function (ast or alt ≥ 100); (10) patients with severely impaired renal function (serum creatinine ≥ 2.0 mg/dl); (11) patients with cancer; (12) patients who were pregnant or lactating; (13) patients with other grave diseases such as hypertensive encephalopathy, aortic dissection, acute myocardial infarction, or severe congestive heart failure; and (14) patients who were allergic to the test or control drugs
development of a molecular diagnostic tool for endometrial cancer.

Conditions: Endometrium Cancer

Summary: womec is an in vitro diagnostic test for endometrial cancer (ec) based on the detection of the expression level of a combination of 5 proteins in the soluble fraction of a pipelle biopsy specimen. the aim of the study consists in validating womec's elisa test, creating and freezing an algorithm to rule out ec in post-menopausal women with abnormal uterine bleeding (aub).


Eligibility criteria:
inclusion criteria: * post-menopausal women (≥1 year without menstruation) with aub who present with: 1. endometrium \> 3mm by transvaginal ultrasound, or 2. endometrium ≤ 3mm who meet at least one of the following criteria: i. persistent symptoms (more than one episode of metrorrhagia) ii. heterogenous endometrium on transvaginal ultrasonography iii. risk factors (bmi ≥ 30, use of tamoxifen, hormone replacement therapy (hrt), lynch syndrome, brca mutation. * obtaining written informed consent exclusion criteria: * women with an active pelvic infection. * women who have had viral infections with evidence of active and latent disease such as hepatitis b, hepatitis c, and hiv infection. patients who have had hepatitis c in the past but who have been successfully treated and in whom viral replication has not been observed in the last year will be included.

Keywords: endometrial cancer, ec
fish oil vs. placebo on subjective effects of alcohol

Conditions: Alcohol Dependence

Summary: this project represents a first step in examining the potential use of fish oil for the treatment of alcohol use disorder (aud). the investigators will be testing for attenuation of alcohol-induced sedative and stimulant effects, as well as cognitive effects and cerebellar effects in healthy social drinkers.

there have been no studies to date that have examined the relationship between fish oil and alcohol response in humans. the current study was designed to examine the relationship between fish oil and subjective alcohol effects in healthy social drinkers. this project represents a first step in examining the potential use of fish oil for the treatment of alcohol use disorder (aud). the investigators will evaluate responses to alcohol through administration of a steady state blood alcohol level (bal) with an iv infusion using a method that employs an infusion that is titrated to a breathalyzer reading and clamped at a steady state. this approach allows direct comparisons of the acute effects of a specific dose of ethanol between groups, without the confounding factors of variable alcohol absorption and peak bal's. this approach will allow the examiners to carefully examine if fish oil changes the acute effects of alcohol on a number of outcome domains including subjective drug effects, cognitive performance, and cerebellar effects. as this study is a pilot study, it is not clear whether fish oil will attenuate alcohol induced subjective stimulation or sedation. since this is the first study to evaluate fish oil's effects on alcohol-effects in the laboratory, the investigators will be testing for attenuation of alcohol-induced sedative and stimulant effects, as well as cognitive effects and cerebellar effects. in this study, fish oil will be administered at 3 grams/day for 30-40 days (3 capsules twice a day). the investigators will use 3 grams/day for two reasons: 1) it is within the range of doses safely used in humans (1g to 6g) as a treatment for various psychiatric conditions (depression, anxiety, borderline personality disorder), and 2) is a dose that has shown efficacy in various clinical trials for psychiatric conditions.

Eligibility criteria:
inclusion criteria: 1. male and females, between the ages of 21 and 55; 2. no current drug use disorder of any drugs of abuse (except tobacco or marijuana); 3. no current medical problems and normal ecg; 4. for women, not pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods. exclusion criteria: 1. current major psychiatric illnesses including mood, psychotic, or anxiety disorders; 2. history of major medical illnesses; including liver diseases, heart disease, chronic pain or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study; 3. liver function tests (alt or ast) greater than 3 times normal; 4. allergy to seafood.

Keywords: alcohol dependence fish oil
nyulmc caresmarts pilot

Conditions: Diabetes; Type 2 Diabetes (T2D)

Summary: caresmarts is a theory-driven behavioral intervention designed to improve self-care among patients with type 2 diabetes (t2d) with poor glycemic control (hba1c\>8%), through multiple mediators, including cuing, education, self-efficacy, social support, and health beliefs. individuals will be randomly assigned with equal allocation to either the caresmarts intervention or to usual care for 6 months.

caresmarts is a mobile diabetes program that provides self-management support and team-based care management for people with diabetes through automated sms messages. the program is a theory-driven behavioral intervention designed to improve self-care through multiple mediators, including cuing, education, self-efficacy, social support, and health beliefs. participants in the program receive educational and motivational text messages about diabetes self-care, some prompts to engage in a particular action (for example, "time to check your blood sugar"), and some self-assessment questions (such as, "do you need refills of any of your medications?") to which the patient responds by texting. participants' responses to self-assessment questions are used to facilitate remote monitoring and care management by the health care team. a response that is outside established parameters triggers an alert. using protocols, nurses respond to each alert by the next business day.

Eligibility criteria:
inclusion criteria: * have a drg code of t2d, and be prescribed at least one oral t2d drug and/or insulin. * must own an sms capable mobile device and be willing to send and receive sms messages regarding t2d self-management. * the participant's physician of record will have verified that his/her patient can safely participant in an intervention study that targets an hba1c \<7%. exclusion criteria: * unable or unwilling to provide informed consent * unable to participate meaningfully in an intervention that involves use of sms messages (e.g., due to uncorrected sight impairment, illiterate, non-english-speaking) * unwilling to accept randomization assignment * pregnant, plans to become pregnant in the next 6 months, or who become pregnant during the study * gestational diabetes * breastfeedling * individuals who are institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have limited control over self-management)

Keywords: caresmarts sms-based mobile
efficacy and safety of asenapine with placebo and olanzapine (41021)(p05933)

Conditions: Schizophrenia

Summary: schizophrenia is a brain disease. the primary features of schizophrenia are characterized by positive symptoms (symptoms that should not be there, inability to think clearly, to distinguish reality from fantasy i.e., hearing voices) and negative symptoms (a reduction or absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and relate to others). other symptoms include reduced ability to recall and learn new information, difficulty with problem solving, or maintaining productive employment. the symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other. asenapine is an investigational drug that may help to correct the imbalance in dopamine and serotonin. this is a 6 week study to test the efficacy and safety of asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia. patients that complete this trial will have the option of continuing in an additional one year extension trial.


Eligibility criteria:
inclusion criteria: * currently suffering from an acute exacerbation of schizophrenia. caregiver required. exclusion criteria: * have an uncontrolled, unstable medical condition. have any other psychiatric disorder other than schizophrenia as a primary diagnosis.